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Last Updated: September 20, 2021

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Claims for Patent: 10,023,917

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Summary for Patent: 10,023,917
Title:High resolution melting analysis as a prescreening tool
Abstract: Compositions and methods for determining an increased likelihood of a response to a targeted treatment of a cancer disease including isolating genomic DNA from a patient sample, amplifying a fragment of DNA by means of PCR with a specific pair of amplification primers, determining if the amplified fragment comprises a wildtype sequence or a mutation by means of a High Resolution Melting Analysis (HRM), and correlating the presence or absence of a mutation with an increased likelihood of success of said targeted treatment. Respective primer pairs, compositions and kits are also claimed.
Inventor(s): Buettner; Reinhard (Villiprott, DE), Froehner; Stefanie (Penzberg, DE), Merkelbach-Bruse; Sabine (Aachen, DE), Ney; Jasmin (Wallerfangen, DE), Roesler; Angelika (Sindelsdorf, DE)
Assignee: Roche Molecular Systems, Inc. (Pleasanton, CA)
Application Number:14/958,567
Patent Claims:1. A method of treating a cancer patient comprising: i) isolating genomic DNA from a sample from the cancer patient; ii) amplifying a fragment of said DNA by means of PCR with a specific pair of amplification primers, thereby forming an amplified fragment; iii) determining that said amplified fragment does not comprise a G13_V14A or G60D mutation in the KRAS gene by means of a High Resolution Melting Analysis (HRM) and DNA sequencing; and iv) treating the cancer patient with an anti-EGFR targeted treatment.

2. The method of claim 1, wherein in step ii, the amplification primers comprise one or more sequences selected from the group consisting of SEQ ID NOs: 9-16.

3. The method of claim 1, wherein the sample is Formalin Fixed Paraffin Embedded (FFPE) tissue.

4. The method of claim 1, wherein said step of determining comprises performing High Resolution Melting Analysis without any spiking of DNA.

5. The method of claim 1, wherein said step of determining comprises comparing HRM analysis results of the amplified fragment to a control.

6. The method of claim 5, wherein the control comprises HRM analysis results of a wildtype sample.

7. The method of claim 1, wherein HRM is performed using a probe selected from a group consisting of SEQ ID NO: 31 or its complement, SEQ ID NO: 32 or its complement, and SEQ ID NO: 33 or its complement.

8. The method of claim 1, wherein the cancer patient has colorectal cancer.

9. The method of claim 1, wherein the anti-EGFR targeted treatment is an anti-EGFR antibody therapy.

10. The method of claim 1, wherein the anti-EGFR targeted treatment is panitumumab or cetuximab.

Summary for Patent: ⤷  Free Forever Trial

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
11150641Jan 11, 2011

Details for Patent 10,023,917

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Imclone ERBITUX cetuximab VIAL; INTRAVENOUS 125084 001 2004-06-18 ⤷  Free Forever Trial Roche Molecular Systems, Inc. (Pleasanton, CA) 2031-01-11 RX Orphan search
Amgen VECTIBIX panitumumab INJECTABLE; IV (INFUSION) 125147 001 2006-09-27 ⤷  Free Forever Trial Roche Molecular Systems, Inc. (Pleasanton, CA) 2031-01-11 RX search
Amgen VECTIBIX panitumumab INJECTABLE; IV (INFUSION) 125147 002 2006-09-27 ⤷  Free Forever Trial Roche Molecular Systems, Inc. (Pleasanton, CA) 2031-01-11 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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